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Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS

NCT00737204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-06-12

Study results available
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Summary

This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.

Conditions

Interventions

DRUG

Armodafinil

Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.

DRUG

Placebo

Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Judith G. Rabkin, Phd, MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-04-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737204 on ClinicalTrials.gov